January 2025 opened with two significant publications.
ICH E6(R3) reaches Step 4
On 6 January 2025 ICH adopted E6(R3), the revised Good Clinical Practice guideline (principles plus Annex 1), completing the rewrite that began with E8(R1). Regional implementation followed, with the EU applying it from July 2025. Our summary of the practical changes is in this article.
FDA draft guidance on AI
FDA issued draft guidance, "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products", proposing a risk-based credibility assessment framework: define the question of interest, define the context of use, assess model risk, and plan credibility activities proportionate to that risk.
What both mean for data teams
Sponsors using AI or advanced analytics in pharmacovigilance, data cleaning or submission work will need to show the model's context of use and credibility evidence, in the same way E6(R3) asks for a documented data flow. Our data analytics and biostatistics teams have begun documenting models this way for clients.